Effects of aspirin dose when used alone or in combination with clopidogrel in patients with acute coronary syndromes - Observations from the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) study

Effects of aspirin dose when used alone or in combination with clopidogrel in patients with acute coronary syndromes - Observations from the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) study
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DOI:
10.1161/01.cir.0000091201.39590.cb
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发表时间:
2003-10-07
期刊:
影响因子:
37.8
通讯作者:
Yusuf, S
Yusuf, S
中科院分区:
医学1区
文献类型:
--
作者:
Peters, RJG;Mehta, SR;Yusuf, S

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背景:我们研究了在不同剂量的阿司匹林中加入氯吡格雷治疗急性冠脉综合征(ACS)患者的获益和风险。方法和结果:在氯吡格雷治疗不稳定心绞痛预防复发事件(CURE)试验中,12562例ACS患者使用阿司匹林,每日75 - 325 mg,随机分为氯吡格雷组或安慰剂组,为期1年。在本分析中,患者被分为以下3个阿司匹林剂量组:小于或等于100mg, 101至199 mg,大于或等于200mg。无论阿司匹林剂量如何,氯吡格雷均可降低心血管死亡、心肌梗死或卒中的综合发生率,具体如下:小于或等于100 mg, 10.5% vs 8.6%(相对危险度[RR], 0.81 [95% CI, 0.68 ~ 0.97]);101 ~ 199 mg, 9.8% vs 9.5% (RR, 0.97 [95% CI 0.77 ~ 1.22]);大于或等于200 mg, 13.6%对9.8% (RR, 0.71 [95% CI, 0.59 ~ 0.85])。在安慰剂组(分别为1.9%、2.8%和3.7%,P=0.0001)和氯吡格雷组(分别为3.0%、3.4%和4.9%,P=0.0009)中,大出血发生率随阿司匹林剂量的增加而增加;因此,氯吡格雷的额外风险分别为1.1%、1.2%和1.2%。阿司匹林最高剂量组与最低剂量组大出血的校正风险比在安慰剂组为1.9 (95% CI 1.29 - 2.72),氯吡格雷组为1.6 (95% CI 1.19 - 2.23),联合组为1.7 (95% CI 1.36 - 2.20)。结论:在ACS患者中,无论阿司匹林的剂量如何,在阿司匹林中加入氯吡格雷都是有益的。出血风险随着阿司匹林剂量的增加而增加,使用或不使用氯吡格雷,但没有增加疗效。我们的研究结果表明,阿司匹林的最佳日剂量可能在75至100毫克之间,有或没有氯吡格雷。
Background-We studied the benefits and risks of adding clopidogrel to different doses of aspirin in the treatment of patients with acute coronary syndrome (ACS).Methods and Results-In the Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial, 12 562 patients with ACS using aspirin, 75 to 325 mg daily, were randomized to clopidogrel or placebo for up to 1 year. In this analysis, patients were divided into the following 3 aspirin dose groups: less than or equal to100 mg, 101 through 199 mg, and greater than or equal to200 mg. The combined incidence of cardiovascular death, myocardial infarction, or stroke was reduced by clopidogrel regardless of aspirin dose, as follows: less than or equal to100 mg, 10.5% versus 8.6% (relative risk [RR], 0.81 [95% CI, 0.68 to 0.97]); 101 to 199 mg, 9.8% versus 9.5% (RR, 0.97 [95% CI 0.77 to 1.22]); and greater than or equal to200 mg, 13.6% versus 9.8% (RR, 0.71 [95% CI, 0.59 to 0.85]). The incidence of major bleeding increased with increasing aspirin dose both in the placebo group (1.9%, 2.8%, and 3.7%, respectively; P=0.0001) and the clopidogrel group (3.0%, 3.4%, and 4.9%, respectively; P=0.0009); thus, the excess risk with clopidogrel was 1.1%, 1.2%, and 1.2%, respectively. The adjusted hazard ratio for major bleeding for the highest versus the lowest dose of aspirin was 1.9 (95% CI 1.29 to 2.72) in the placebo group, 1.6 (95% CI 1.19 to 2.23) in the clopidogrel group, and 1.7 (95% CI 1.36 to 2.20) in the combined group.Conclusions-In patients with ACS, adding clopidogrel to aspirin is beneficial regardless of aspirin dose. Bleeding risks increase with increasing aspirin dose, with or without clopidogrel, without any increase in efficacy. Our findings suggest that the optimal daily dose of aspirin may be between 75 and 100 mg, with or without clopidogrel.